Axiom Artis Modular Angiography System

• • Terminated Z-0711-2018 FDA Class II ·initiated 28 Sep 2017 ·on shared 510(k) K010721

  The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. The hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible.

• • Terminated Z-2393-2016 FDA Class II ·initiated 13 Jul 2016

  The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.

• • Terminated Z-2342-2015 FDA Class II ·initiated 29 Jun 2015

  The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.

• • Terminated Z-2587-2014 FDA Class II ·initiated 5 Jun 2014

  There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand switch operated at the patient table which may result in uncontrolled release of an x-ray image.

• • Terminated Z-2233-2010 FDA Unclassified (pre-2012) ·initiated 13 Jul 2010

  The Axiom Artis MP, Artis dMP or Artis zee Multipurpose C-arm gearbox can become damaged. If the gearbox is damaged, the C-arm may tilt away when being repositioned and collide with nearby objects in its range of motion.

• • Terminated Z-0483-2010 FDA Unclassified (pre-2012) ·initiated 26 Oct 2009

  c-arm may tilt

• • Terminated Z-1439-2009 FDA Unclassified (pre-2012) ·initiated 1 May 2009

  Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall.

• 9 recalls, same reason

  • Terminated Z-0127-2009 FDA Unclassified (pre-2012) ·initiated 2 Sep 2008
  • Terminated Z-0124-2009 FDA Unclassified (pre-2012) ·initiated 2 Sep 2008
  • Terminated Z-0123-2009 FDA Unclassified (pre-2012) ·initiated 2 Sep 2008
  • Terminated Z-0126-2009 FDA Unclassified (pre-2012) ·initiated 2 Sep 2008
  • Terminated Z-0122-2009 FDA Unclassified (pre-2012) ·initiated 2 Sep 2008
  • Terminated Z-0120-2009 FDA Unclassified (pre-2012) ·initiated 2 Sep 2008
  • Terminated Z-0125-2009 FDA Unclassified (pre-2012) ·initiated 2 Sep 2008
  • Terminated Z-0121-2009 FDA Unclassified (pre-2012) ·initiated 2 Sep 2008
  • Terminated Z-0128-2009 FDA Unclassified (pre-2012) ·initiated 2 Sep 2008

  Incorrect contour finding: Image may be calibrated to the wrong size catheter.

• • Terminated Z-0193-2009 FDA Unclassified (pre-2012) ·initiated 22 Aug 2008

  Patients could possibly fall off the table if not properly secured when: 1) moving them onto the patient table, 2) moving them on the patient table or 3) removing them from the patient table.

• • Terminated Z-0579-2007 FDA Unclassified (pre-2012) ·initiated 31 Jan 2007

  C-arm gantry could rapidly descend without command during use

• • Terminated Z-0578-2007 FDA Unclassified (pre-2012) ·initiated 31 Jan 2007

  C-arm gantry could rapidly descend without command during use.

• • Terminated Z-0796-05 FDA Unclassified (pre-2012) ·initiated 11 Apr 2005

  Live display in exam room may sporadically stop working although the display in the control room remains fully operational

• • Terminated Z-0818-05 FDA Unclassified (pre-2012) ·initiated 1 Apr 2005

  potential problem with the fluoroscopy switch on the power grip

• 2 recalls, same reason

  • Terminated Z-1449-04 FDA Unclassified (pre-2012) ·initiated 10 Aug 2004
  • Terminated Z-1450-04 FDA Unclassified (pre-2012) ·initiated 10 Aug 2004

  Opacification Function of device may incorrectly merge images

• • Terminated Z-1108-04 FDA Unclassified (pre-2012) ·initiated 2 Jun 2004

  Error appears in the AUTOMAP function, Module 2, when PERISTEEPING or PERIVISION is activated simultaneously that causes system to crash.

• • Terminated Z-0848-04 FDA Unclassified (pre-2012) ·initiated 28 May 2003

  patient images misidentified

• • Terminated Z-0347-03 FDA Unclassified (pre-2012) ·initiated 5 Aug 2002

  Set delay time for contrast injection exceeds 10 seconds, radiation release button is blocked.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K010721 ↗

FDA Product Code

IZI

Device Class

Class II

Regulation

21 CFR Part 892.1600

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Numaris 4VA15A

  Class II

  FDA 510(k) K012202 Active Cleared 27 Sep 2001

• Siemens Integrated Operating System (SIOS)

  Class II

  FDA 510(k) K994231 Active Cleared 10 Aug 2000

• 3D-Angio

  Class II

  FDA 510(k) K984634 Active Cleared 12 Mar 1999

• Magnetom Open Viva with Permanent Magnet

  Class II

  FDA 510(k) K994316 Active Cleared 14 Jan 2000

• What is the AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM used for?

  The AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM is intended for diagnostic imaging as an X-ray angiographic device, used in radiology settings to visualize blood vessels and support clinical diagnosis.

• Is the AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM sterile or single-use?

  The device is not described as sterile or single-use in the provided data; it is a reusable system designed for repeated use in radiology departments after appropriate cleaning and maintenance between procedures.

• What regulatory pathway was used for the AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM?

  The system received FDA 510(k) clearance through a traditional review process, with clearance granted on March 30, 2001, under K010721, based on a finding of substantial equivalence to a predicate device.